Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients - Clinical Trial for Acromegaly | NCT01278342

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Sandostatin LAR

pegvisomant

cabergoline

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Sandostatin LAR, High Dose, GH-receptor antagonist, combination with dopamine-agonist, acromegalic patients, octreotide acetate, Somavert, Dostinex, pegvisomant, cabergoline, not adequately controlled, active acromegaly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender)

Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level
Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion

Exclusion Criteria:

Newly diagnosed or previously medically untreated acromegalic patient
Concomitant treatment with GH-receptor antagonist
Concomitant treatment with dopamine-agonist
Symptomatic cholelithiasis or choledocolithiasis
Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory)
Previous gamma-knife radiotherapy for treatment of acromegaly
Compression of the optic chiasm causing visual field defect
Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Sandostatin LAR high dose Alone

Sandostatin LAR high dose + Pegvisomat

Sandostatin LAR high dose + Cabergoline

Arm Description

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows: st week: 0.25 mg twice a week (0.50 mg/week) nd week: 0.50 mg/week twice a week (1 mg/week) rd week: 0.50 mg four times a week (2 mg/week) th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Outcomes

Primary Outcome Measures

The Percentage of Participants With Complete Response (CR) at 8 Months

A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment: Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and IGF-I within the Central Laboratory Normal Range (for age and gender).

Secondary Outcome Measures

The Percentage of Participants With Complete Response (CR) At 3 Months

A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment: Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and IGF-I within the Central Laboratory Normal Range (for age and gender)

The Percentage of Participants With Partial Response (PR) at 8 Months

Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment. Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range. Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range.

Full Information

NCT ID

NCT01278342

First Posted

January 14, 2011

Last Updated

February 28, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01278342

Brief Title

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients

Acronym

HOSCAR

Official Title

An Open-label, Two-step, Multicenter European Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients Not Adequately Controlled by Conventional Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

Keywords

Sandostatin LAR, High Dose, GH-receptor antagonist, combination with dopamine-agonist, acromegalic patients, octreotide acetate, Somavert, Dostinex, pegvisomant, cabergoline, not adequately controlled, active acromegaly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sandostatin LAR high dose Alone

Arm Type

Active Comparator

Arm Description

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.

Arm Title

Sandostatin LAR high dose + Pegvisomat

Arm Type

Experimental

Arm Description

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR40 mg every 28 days in combination with weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months

Arm Title

Sandostatin LAR high dose + Cabergoline

Arm Type

Experimental

Arm Description

All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and or IGF-I received Sandostatin LAR 40 mg every 28 days in combination with weekly cabergoline for a further 4 months, with cabergoline doses as follows: st week: 0.25 mg twice a week (0.50 mg/week) nd week: 0.50 mg/week twice a week (1 mg/week) rd week: 0.50 mg four times a week (2 mg/week) th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Intervention Type

Drug

Intervention Name(s)

Sandostatin LAR

Other Intervention Name(s)

octreotide acetate

Intervention Description

40 mg intramuscular (i.m.) every 28 days for 3 months

Intervention Type

Drug

Intervention Name(s)

pegvisomant

Other Intervention Name(s)

Somavert, octreotide acaetate

Intervention Description

Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months

Intervention Type

Drug

Intervention Name(s)

cabergoline

Other Intervention Name(s)

Dostinex, octreotide acetate

Intervention Description

Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows: st week: 0.25 mg twice a week (0.50 mg/week) nd week: 0.50 mg/week twice a week (1 mg/week) rd week: 0.50 mg four times a week (2 mg/week) th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)

Primary Outcome Measure Information:

Title

The Percentage of Participants With Complete Response (CR) at 8 Months

Description

A patient was classified as a Complete Responder (CR) if both biochemical parameters were controlled at the end of 8 months of treatment: Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and IGF-I within the Central Laboratory Normal Range (for age and gender).

Time Frame

From Baseline to 8 months

Secondary Outcome Measure Information:

Title

The Percentage of Participants With Complete Response (CR) At 3 Months

Description

A patient was classified as CR if both biochemical parameters were controlled at the end of 3 months of treatment: Mean 1 hour GH < 2.5µg/L (according to Central Laboratory); and IGF-I within the Central Laboratory Normal Range (for age and gender)

Time Frame

From Baseline to 3 months

Title

The Percentage of Participants With Partial Response (PR) at 8 Months

Description

Patients who met one of the following criteria at the end of 8 months of treatment were defined as Partial Responders, regardless of the treatment. Mean 1 hour GH > 2.5 µg/L and < 5 µg/L and either a decrease in IGF-I of at least 50% compared to baseline or IGF-I within normal range. Mean 1 hour GH < 2.5 µg/L and a decrease in IGF-I of at least 50% compared to baseline and IGF-I outside normal range.

Time Frame

From Baseline to 8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: • Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender) Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion Exclusion Criteria: Newly diagnosed or previously medically untreated acromegalic patient Concomitant treatment with GH-receptor antagonist Concomitant treatment with dopamine-agonist Symptomatic cholelithiasis or choledocolithiasis Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory) Previous gamma-knife radiotherapy for treatment of acromegaly Compression of the optic chiasm causing visual field defect Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Novartis Investigative Site

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Novartis Investigative Site

City

Kremlin-Bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

Novartis Investigative Site

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Novartis Investigative Site

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

Novartis Investigative Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novarts Investigative Site

City

Naples

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

ZIP/Postal Code

06126

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

91-425

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

Country

Poland

Facility Name

Novartis Investigative Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

CH-1011

Country

Switzerland

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients (HOSCAR)

Acromegaly

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial